MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

Device Problem Output below Specifications (3004)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2023

Event Type  malfunction  

Manufacturer Narrative

Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.

Event Description

It was reported that the patient was seen by their physician.The patient had not been able to feel stimulation for the past month.Low output current was seen upon device interrogation.An error message was seen that read, ¿low output current ¿ please lower output current, increase pulse width, and try again.¿ once the parameters were adjusted and diagnostics were run again, the low output message went away.The physician adjusted the parameters back to their original settings, and no low output current was seen; however, the patient could still not feel stimulation.The output current was increased to the max value and pulse width, and stimulation could still not be perceived.The physician was concerned this indicated a device malfunction, so the patient was admitted to the hospital for an urgent battery replacement.Post battery replacement, patient was able to feel stimulation again.The suspect generator has been received by the manufacturer to undergo product analysis.Analysis has not been completed to date.No other relevant information has been received to date.

Event Description

Product analysis was completed on the returned generator.The electrical tests performed in the pa lab found that the generator was at an intensified follow-up indicator (ifi) = no condition.The device output signal was monitored for more than 24-hrs and a comprehensive automated electrical evaluation was performed.Magnet activations were performed during monitoring, and the magnet output current maintained as programmed.No anomalies were seen, and the device performed according to functional specifications.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 16942937
• MDR Text Key: 315362998
• Report Number: 1644487-2023-00606
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/02/2022
• Device Model Number: 1000
• Device Lot Number: 6777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2023
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Sex: Female